Recordkeeping for electronic prescriptions for controlled substances

Forms and Documents

Document	Type	Status	Availability

No forms / supporting documents in this ICR. Check IC Document Collections.

IC Document Collections

IC ID	Collection	Type	Status	Form
183687	Recordkeeping for electronic prescriptions for controlled substances (Providers)		New
183654	Recordkeeping for electronic prescriptions for controlled substances (Practitioners)		New

ICR Details

OMB Control No: 1117-0049	ICR Reference No: 200802-1117-001
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: DOJ/DEA	Agency Tracking No:
Title: Recordkeeping for electronic prescriptions for controlled substances
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 06/24/2008
	Date Received in OIRA: 02/07/2008
Terms of Clearance: DEA will incorporate public comments for the final submission.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: DEA would require that service providers check a government-issued photographic identification and the validity of a registrant's DEA registration and State license and retain a record of the check. DEA would require practitioners to review, on a monthly basis, a log of controlled substance prescriptions they have written and indicate that they have done so. The service provider would be required to retain a record that the log was reviewed and would be required to retain a digitally signed copy of the prescription as transmitted. Pharmacy systems would be required to digitally sign and archive the prescription as received. All service providers would be required to post a copy of the report of an annual third-party audit.

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Authorizing Statute(s): US Code: 21 USC 827 Name of Law: Records and Reports of Registrants
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
1117-AA61	Proposed rulemaking

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Recordkeeping for electronic prescriptions for controlled substances (Practitioners)
Recordkeeping for electronic prescriptions for controlled substances (Providers)

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new collection. DEA is proposing to revise its regulations to allow controlled substances prescriptions to be written, transmitted, and maintained as electronic data files. To do this, DEA is proposing certain security requirements to ensure that only DEA registrants are authorized to issue controlled substance prescriptions and that a legally defensible electronic record is created and maintained to provide forensic evidence for law enforcement to use in legal actions against individuals engaged in diversion. The electronic prescriptions are not covered by this ICR as these records are part of normal business records that pharmacies are required to retain under State law.

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 02/07/2008

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